SPASIL TABLET

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULPHATE

Boleh didapati daripada:

IMEKS PHARMA SDN. BHD.

INN (Nama Antarabangsa):

DIPHENOXYLATE HYDROCHLORIDE; ATROPINE SULPHATE

Unit dalam pakej:

100 Tablets; 1000 Tablets

Dikeluarkan oleh:

Sriprasit Pharma Co. Ltd.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
SPASIL TABLET
Diphenoxylate hydrochloride / Atropine sulphate (2.5mg / 0.025mg)
_ _
1
WHAT IS IN THIS LEAFLET
1.
What SPASIL is used for
2.
How SPASIL works
3.
Before you use SPASIL
4.
How to use SPASIL
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of SPASIL
8.
Product Description
9.
Manufacturer and Product Registration
Holder
10.
Date of Revision
WHAT SPASIL IS USED FOR
SPASIL is used for symptomatic treatment
of diarrhoea.
SPASIL can be given after the colostomy or
ileostomy surgery to reduce the frequency
and fluidity of the stools.
HOW SPASIL WORKS
SPASIL
contains
the
active
ingredients
diphenoxylate
hydrochloride
and
atropine
sulphate.
Diphenoxylate
hydrochloride
reduces
diarrhoea by slowing down the movement of
the
intestines.
Because
diphenoxylate
hydrochloride is an opioid, it may be abused
by taking it in doses that are larger than
prescribed.
Therefore,
a
small
amount
of
atropine sulphate is included in SPASIL to
prevent drug abuse.
BEFORE YOU USE SPASIL_ _
-
_When you must not use it_
Do not take SPASIL if you:
• are allergic to diphenoxylate hydrochloride,
atropine sulphate or any ingredients in the
formulation.
•
have
jaundice
(yellowing
of
skin
and
whites of eye).
•
have
intestinal
obstruction,
ulcers
and
inflammation in the digestive tract.
•
have
diarrhoea
caused
by
pseudomembranous enterocolitis. This is a
potentially serious infection of the gut, which
may occur following antibiotic treatment.
• have a raised pressure in your skull or head
injury.
•
have
muscle
weakness
including
those
affecting your intestinal movement.
• have prostatic enlargement.
-
_Before you start to use it _
Tell your doctor if you have allergies to any
medicines, foods, preservatives or dyes.
Tell
your
doctor
if
you
have
any
other
medical conditions, especially:
- Liver disease
- Kidney disease
- Down’s syndrome
- History of drug abuse
Appropriate
fluid
and
electrolyte
therapy
should be taken to prevent dehydration due
to
diarrhoea.
Or

Ciri produk

SPASIL TABLET
DIRECTIONS FOR USE PLEASE READ CAREFULLY!
CONTENT
Diphenoxylate hydrochloride
2.5 mg
Atropine sulphate
0.025 mg
DESCRIPTION
White round biconvex tablet embossed with ‘SPS’ on one side and
with
a bisect on the other side.
INDICATION
_SPASIL_ tablet is used in the symptomatic treatment of acute and
chronic diarrhoea. In patients with colostomies or ileostomies, _
SPASIL_
tablet may be used to reduce the frequency and fluidity of the stools.
RECOMMENDED DOSAGE
Adults
Take 1 to 2 tablets three or four times a day or as directed by the
physician. Do not exceed 8 tablets in 24 hours.
Stop treatment when bowel movements return to normal. Consult
doctor if diarrhoea is bloody or persists for more than 3 days.
Children
6 to 8 years of age:
1 tablet 3 times daily
9 to 12 years of age:
1 tablet 4 times daily
For oral administration.
Not recommended for children under 6 years of age.
CONTRAINDICATIONS
Patients with known hypersensitivity to diphenoxylate hydrochloride or
atropine.
In patients with jaundice, intestinal obstruction, acute ulcerative
colitis,
in the treatment of diarrhoea associated with pseudomembranous
enterocolitis, and in patients with a raised intracranial pressure,
and
patients with head injury.
Contraindicated in myasthenia gravis, pyloric stenosis, paralytic
ileus
and prostatic enlargement.
WARNING AND PRECAUTIONS
In the presence of severe dehydration and electrolyte imbalance,
corrective therapy must be initiated before _ SPASIL_ tablet is given.
Appropriate fluid and electrolyte therapy should be given to protect
against
dehydration
in
all
cases
of
diarrhoea.
Oral
rehydration
therapy,
which
is
the
use
of
appropriate
fluids
including
oral
rehydration salt, remains the most effective treatment for dehydration
due to diarrhoea. The intake of as much of these fluids as possible is
therefore imperative. Drug-induced inhibition of peristalsis may
result in
fluid detention in the intestine, which may aggravate and mask
dehydration
and
depletion
of
electrolytes,
especially
in
young
children.